Quality Associate II

Overview

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Responsibilities

• Assist in maintaining the Document Control Center and relevant Standard Operating Procedures (SOPs) for the proofing, filing, copying, scanning, archiving, retrieval, and maintenance of all controlled documents and records required by applicable regulations.
• Serve as custodian for all controlled documents and records filed in the Document Control Center and archived at the on-site warehouse or off-site contracted storage facility.
• Responsibility for storage, retrieval, and archiving of controlled documents and records.
• Filing master copies of new or revised controlled documents in the Document Control Center and archiving obsolete documents as instructed in relevant departmental SOPs.
• Performing tasks for the distribution of controlled documents (hard copy or electronic) and for the retrieval of obsolete documents from circulation.
• Updating document histories and controlling obsolete documents.
• Performing tasks for the maintenance of the controlled documents master lists/database to identify current revisions.
• Tracking, monitoring, and reporting of training status.

Qualifications

• Minimum Knowledge & Experience required for the position: Associate’s degree or equivalent, or 6 months to 1 year of related experience.
• Exceptional organizational skills.
• Ability to proofread controlled documents with a keen eye for detail, receive direction well and work independently.
• Excellent verbal and written communication skills.
• Proficient with Microsoft Excel, Word, Access, and Outlook.

Closing

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.